31/01/2006© European and International Certification for Pharmaceutical Packaging Materials The development of an International Standard for Pharmaceutical Packaging Materials Tony Harper Principal UK Expert to ISO/TC 76 WG 6

31/01/2006© European and International Standards UK France Germany Sweden ISO

31/01/2006© European Certification Certipharm – France QAPP (Quality Association for Pharmaceutical Packaging) – Germany PQG (Pharmaceutical Quality Group) – UK Sweden International Certification Bodies AJA, BSI, BVQI, DNV, LRQA, NQA, NSAI, SGS-Y, TUV & more to come?

31/01/2006© European Certification Standards Auditors Training Certification Co-operation Recognition Harmonisation.

31/01/2006© European Certification France, Germany and UK Meetings Comparison of standards Comparison of auditing Witnessed audits, two in each country planned Evaluation Process for recognition to be defined and then work towards harmonisation of standards, auditor training, auditing and certification Other interested parties & countries welcome! Please volunteer – particularly to work on ISO 15378!!

31/01/2006© Auditor Certification Standards in Europe are similar Standard of auditing varies Need to harmonise Use PQG Auditor Scheme as a basis? Extend to Europe?? Extend Worldwide???

31/01/2006© UK Standards Codes of Practice – P00020 Raw Materials P00021 Printed Components P00022 Contact Packaging PS 9000: >>>>> Contact & Packaging in one Standard PS 9004:2004 Guide to the GMP requirements of PS 9000.

31/01/2006© French Standards Certipharm GMP requirements for suppliers Reading Guide French translation of PS 9000!

31/01/2006© German Standards Quality Association Pharmaceutical Packaging – QAPP Membership of QAPP mandatory for Certification Secondary Packaging Material Suppliers only QAPP GMP Standard Good level of validation.

31/01/2006© Sweden PS 9000 Translated into Swedish Cerbo – Primary (Trollhattan) & Secondary Packaging Materials (Gothenburg) Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad).

31/01/2006© International Standards ISO 15378:2006 Includes all of ISO 9001:2000 Additional requirements for packaging materials 2006 version – primary packaging only Mandatory Annex for Printed Components Guidance Annexes for Risk management and Validation.

31/01/2006© Development process Initial German ‘ad-hoc’ meeting, 2002 Ad-hoc group within ISO/TC 76, 2003 Initial drafts, limited circulation, UK involvement, suggested significant changes, Ad-hoc group became ISO/TC 76 WG 6 NWI – ISO New Work Item: ISO

31/01/2006© ISO/TC 76 “Infusion, transfusion and medical equipment”! Not the ideal ‘home’ Limited contacts (internationally) Drafts did not reach the people who could comment Input limited to the ‘few’ Composition of WG 6 was unbalanced.

31/01/2006© UK Input UK Team Tony Harper Roy Evans Jill Jenkins Steve Taylor Ashok Chand David Abraham Antoinette Devine Bill Hewlett Mike Shorten John Turner ….. and others - maybe some of you!

31/01/2006© What did UK do! Ensured a more consistent approach Removed many errors Identified omissions Made significant additions based on PS 9000 Turned the draft into an auditable document Assisted the Secretariat with editing.

31/01/2006© The result!

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31/01/2006© ISO – Key Requirements Records Internal communication GMP Training 6.4 Work environment 6.5 Maintenance Customer communication Purchasing 7.5 Cleanliness & contamination control OOS (Out of Specification) 8.3 Non-conforming product.

31/01/2006© The (2) key annexes Annex B – Validation Annex C – Risk Management These two annexes although ‘Normative’, i.e. guidance, are probably the most significant additions to PS 9000 and were developed by an International team.

31/01/2006© ISO 15378:2006 Publication expected 31/03/06 Certification will follow Glass companies expected to lead the way – Internationally ‘Others’ will follow What will PQG do to promote and encourage?

31/01/2006© What next? Extend the scope for Secondary Packaging Materials Produce a supporting Guidance document And how do these fit in? >>>>>>>>>>>

Scope Detail & Auditor competence ISO 9001 GMP (GxP) Principles GMP Guidance ISO GMP = ISO 15378

Q7a A P I s I S O PS9000PS9000 GMPGMP ExcipientsExcipients IPAC-RSIPAC-RS Primary Packaging materials ISO 9000 Inhalation

31/01/2006© Any questions please?